Cleared Traditional

KAEN YIH UMBILICAL CORD CLAMP

K033846 · Kaen Yih Enterprise Co., Ltd. · Obstetrics & Gynecology

Mar 2004

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K033846 is an FDA 510(k) clearance for the KAEN YIH UMBILICAL CORD CLAMP, a Clamp, Umbilical (Class II — Special Controls, product code HFW), submitted by Kaen Yih Enterprise Co., Ltd. (Mc Henry, US). The FDA issued a Cleared decision on March 11, 2004, 91 days after receiving the submission on December 11, 2003. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K033846 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2003
Decision Date	March 11, 2004
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement